New Biological Applications (BLA) - The Future of Pharmaceuticals

In August 2010, Pharmaceutical Technology published a report of Bornadata Bain and John Shortmoor (Pharmaceutical Technology, Volume 34, pp. s38-s45) about the future development of the pharmaceutical market. During the next five years, this article states, the patents of many classic blockbuster products will end and this will cause a decrease of the value of the classic market of small molecule products. The pharmaceutical companies need new approved products to adjust this expected decrease and the research for new blockbuster products seems to be less promising.

For this reason, the most of the leading pharmaceutical companies strengthen their efforts in the field of new biological drugs and orphan drugs. 27% of the new drug approvals in US are Biological Licensed Applications (BLA). This number represents the highest proportion of biologic approvals since 2003. Furthermore, the number of orphan drugs designation doubled in the US in the last decade. The European Medicines Agency EMA registered the highest number of drugs with orphan drug status since European orphan-medicines legislation was introduced in 2000.

The Focus of the leading pharmaceutical companies concentrates on monoclonal antibodies (mAbs), therapeutic proteins, and vaccines, because they expected a strong growth of such products. Currently, 32 of the top 50 companies are now in those sectors.

The authors see a growing importance of biological products for the future, even though blockbuster drugs will provide the bulk of sales for the top 50 pharmaceutical companies (excluding generic-drug companies).

The ECA Course “cGMP Compliance for Biopharmaceuticals” in Berlin, Germany, from 3 to 5 November 2010 provides you with an insight into the GMP requirements in the different stages of development and manufacturing of biopharmaceutical products.

Author:Axel H. Schroeder On behalf of the European Compliance Academy (ECA)

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